BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,30+4L NK,14X09X130

    MDR report key: 3090727 · Received May 2, 2013

    Report

    Report Number
    1818910-2013-04428
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    December 23, 2007
    Report Date
    February 24, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191202 SROM*STM ST,30+4L NK,14X09X130 FEMORAL STEM JDI DEPUY INTERNATIONAL 2334267

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention